- Getinge (Wayne, NJ)
- …and program effectiveness while performing selected audits to evaluate the Quality Management System's compliance and efficiency. The position partners ... collaboration and maintaining a proactive, solution-oriented mindset. Proficiency with electronic Quality Management Systems (eQMS), audit management … more
- Merck & Co. (Rahway, NJ)
- …learned.clinicaltrialjobsEligibleforERPRequired Skills: Accountability, Accountability, Adaptability, Clinical Data Management , Clinical Development, Clinical ... quality activities within the assigned therapeutic area.- This includes operational quality management and inspection management activities.The CQOM will… more
- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... and sites, providing support during health authority inspections, and offering guidance on quality issues . Ensuring vendors adhere to relevant quality … more
- Legrand AV, Inc. (Fairfield, NJ)
- …controls and coordinate measurement device calibration. Learn and assist in creating quality management system documentations such as process maps, procedures ... which will improve process capability and performance. Learn about supplier quality management , including supplier audits, ongoing performance evaluation, … more
- Merck & Co. (Rahway, NJ)
- …Content Management , Content Management Systems (CMS), Cross-Cultural Awareness, Data Management , Data Quality Assessments, Documentation Review, ... questions and issues related to submission content management , quality and standards complianceEngage across functional...process requirementsDevelop and evaluate metrics as part of a data quality monitoring plan to determine where… more
- Legrand AV, Inc. (Fairfield, NJ)
- …systems. Drive project planning, scheduling, resource allocation, and risk management across cross-functional teams. Collaborate with engineering, supply chain, ... project deliverables are aligned with business objectives related to safety, quality , delivery and cost Consistently communicate to internal stakeholders outlining… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operate PPM systems and processes.- Apply AI tools to automate and improve portfolio data quality .- Onboard new projects and teams to PPM systems.- Assist with ... training modules and support decision-making for global/regional projects Evolve Project Management (PM) Processes: - Contribute to improving project management … more
- Legrand AV, Inc. (Fairfield, NJ)
- …These improvements would target processes and procedures that will enhance the quality and repeatability of the assembly process and increase productivity. DUTIES ... in new product design reviews to identify design for manufacturability (DFM) issues and opportunities Review assembly documentation for accuracy through ECO reviews… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …etc.)-Ensure operational study-level timeline, budget, deliverables and quality management -Facilitate escalation and resolution of issues with CRO/ vendors/ ... the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery-Lead...with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical… more
- Merck & Co. (Rahway, NJ)
- …ensure raw materials are ordered and available for manufacturing activities Lead data management activities related to communication through FLEx Scheduling and ... (3) years' experience in a functional area, such as Operations, Management , Quality , Technical Operations, Technology, Engineering Preferred Experience and… more
- Merck & Co. (Rahway, NJ)
- …acumen supporting pre- and post-implementation processes.Proficient in order processing, sales/customer data management , operational management and process ... and end customers.Develop strategic plans to develop or evolve processes/platforms ensuring data reliability/ quality , scalability and business rules to ensure a… more
- Merck & Co. (Rahway, NJ)
- …collaborate closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success ... to ensure compliance with industry regulations.- Able to report any recurring issues or trends to management for further investigation.Cleanroom Environment:… more
- Merck & Co. (Rahway, NJ)
- …Instrument data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware, ... execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational… more
- Novartis Group Companies (East Hanover, NJ)
- … Data Management , Cross-Functional Team, Data Architecture, Data Governance, Data Management , Data Quality , Data Science, Data ... and able to take the right decisions to solve issues at the trial/program delivery level. Participate in Health...Drug Development with at least 6 years' in Clinical Data Management 4 years line management… more
- Novartis Group Companies (East Hanover, NJ)
- … Architecture, Data Governance, Data Integration, Data Management , Data Profiling, Data Quality , Data Science, Data Strategy, Master ... Job Description Summary About the role: Love clinical data management ? Bring that passion to...and documentation across assigned programs, ie ensuring consistency across data quality plans * Ensure alignment with… more
- Merck & Co. (Rahway, NJ)
- …and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial ... patients we serve. Problem Solving and Innovative Thinking:-- Gathers and analyzes data and effectively responds to new or complex situations, developing creative… more
- Merck & Co. (Rahway, NJ)
- …equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level support to CSO when ... collaborate regularly with upstream operations (eg manufacturing, devices) as well as Quality and Safety in ensuring GCS readiness to support the future… more
- ValSource, Inc. (Rahway, NJ)
- …Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality , and risk is ... Requirements Minimum of 7 years’ experience with increasing responsibility in validation/ quality service and project management of life sciences, biotech… more
- Merck & Co. (Rahway, NJ)
- …Accountability, Adaptability, Analytical Testing, Automation, Clinical Trials, Communication, Data Analysis, Detail-Oriented, Deviation Management , Equipment ... and IT teams.Support establishment of GxP systems in the facility: Change Management , Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP… more
- Merck & Co. (Rahway, NJ)
- …Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Research Management , Clinical Studies, Clinical Testing, Clinical Trials, Data ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new… more
